510(k) Report

FDA applicant

Omnilife Science

Raynham, MA7 decisions2007–20211 recall

FDA records 7 decisions for Omnilife Science (Raynham, MA) from 2007 to 2021: 7 510(k) clearances. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Since 2016 its 510(k)s took a median of 139 days from receipt to decision, against 188 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Omnilife Science’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12014: 12015: 12017: 32021: 1
2007high 3 (2017) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Omnilife Science by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…3decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 139 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 188 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 31 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062489Apex Hcla Acetabular Cup LinersOmnilife Science · 20075cite it
  • K133381Omni Arc Monoblock Hip StemOmnilife Science · 20142cite it
  • K153437Apex Revision Knee SystemOmnilife Science · 20151cites it
  • K163332Apex Revision Knee SystemOmnilife Science · 20171cites it

What has FDA decided for it lately?

  • K201611Apex Knee SystemOmnilife Science · 2021
  • K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science · 2017
  • K171156OMNI Anseris Hip StemOmnilife Science · 2017
  • K163332Apex Revision Knee SystemOmnilife Science · 2017
  • K153437Apex Revision Knee SystemOmnilife Science · 20151 recall
  • K133381Omni Arc Monoblock Hip StemOmnilife Science · 2014
  • K062489Apex Hcla Acetabular Cup LinersOmnilife Science · 2007

All 7 as Omnilife Science →

What has been recalled?

1 recall linked to its devices; the latest:

  • K101994Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130…May 23, 2025Class II